Intravenous artesunate for treatment of patients with severe malaria: position statement of TropNet

Severe falciparum malaria is an acute emergency with a very high case fatality rate, if left untreated. The condition warrants immediate onset of therapy with the most rapidly effective drug regimen possible. Quinine, the current drug of choice in Europe and the only licensed antimalarial for i.v.-use, is becoming increasingly unavailable. Thus, the survival of malaria patients is severely threatened due to supply problems. Recent studies have shown a clinical advantage for use of i.v. artesunate versus i.v. quinine in patient survival and reduction of adverse events in severe malaria. A meta-analysis of recent work in Asia showed a highly significant mortality odds ratio of 0.57 in favour of treatment with i.v. artesunate. In the largest study of this series, mortality was reduced from 22% in patients treated with i.v. quinine to 15% in those receiving i.v. artesunate ( Lancet 2005;366:717-25). In view of optimal patient care, published data warrant the immediate use of i.v. artesunate. Unfortunately, there is currently no product available that is produced under GMP conditions. The product that has been used in all recent studies was provided by Guilin Pharmaceutical Factory No 2, Guangxi, People´s Republic of China. TropNet recommends the application of i.v. artesunate in patients with severe malaria despite the unresolved issue of lacking GMP standards of the currently available artesunate formulation. A GMP-manufactured product of this drug should be introduced and distributed in Europe as soon as possible. The quality of the product used should be confirmed by international studies. Quality controls of single batches should be available. TropNet will be monitoring patients who have received this drug. (Date: 31. Oct. 2005)